cGMP Compliance

cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. Manufacturer’s that adhere to cGMP regulations adequately control their manufacturing operations through establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. Manufacturers that follow proper cGMP assure the identity, strength, quality, and purity of the products they manufacture.

cGMP compliance is critical for any manufacturer within a regulated, or soon to be regulated, industry. Proper cGMP compliance provides the government and your consumers peace of mind by ensuring the consistent quality and potency of your products. With decades of experience in the pharmaceutical, medical device, tobacco, cosmetics, nutraceuticals, and cannabinoid industries, Accorto can lead you through the design, implementation, and maintenance of a cGMP compliant Quality Management System that will help prevent instances of contamination, product deviation, and manufacturing errors.

Traceability

While raw material traceability is a critical part of cGMP, many times brand holders of cannabinoid products are asked to provide levels of traceability that go above and beyond what would typically be required in other regulated industries. Some states require companies to provide chain of custody back to the field, or even the original seed source for the cannabinoids in their products. Many states also require companies to provide full product transparency to consumers, requiring batch-specific testing results be available to consumers on-demand for each product.

Accorto can assist with identifying suppliers throughout the manufacturing process that will support your business’s traceability requirements. Additionally, our team can help you implement a variety of quality and data validation systems to provide your customers with required testing and product data reports.

Product Testing

Proper product testing in the cannabinoid industry is critical to product quality and safety; however, few labs specialize in cannabinoid testing and even fewer can keep up with the rapidly evolving market to provide accurate measurements. Many labs still fail to accurately measure ∆9-THC content in ∆8-THC blends, which in cases where the ∆9-THC content is higher than the legal limit, can result in putting both consumers and your company at risk.

Our team understands the importance of proper product testing and has multiple labs in our Network that specialize in cannabinoid testing, providing accurate data to ensure your products meet safety and potency standards.

Our network labs can test for:

• Cannabinoid Potency
  • Delta 8, delta 9, and delta 10
• Terpenes
• Pesticides
• Heavy Metals
• Residual Solvents
• Microbials
• Mycotoxins

State and Local Compliance

While the FDA is in the process of working with congress on a regulatory pathway on a national level, CBD is currently regulated at a state-level, with each state operating under their own laws and regulations. Brand holders currently selling their products across the nation must be conscious of each state’s regulatory laws regarding CBD to ensure compliance and avoid encountering legal pitfalls. The Accorto team help you achieve compliance with state and local regulations, providing you with simple and concise instructions on how to make sure your products are compliant in any location you sell. From labeling, packaging, flavors, formats, strengths, and testing requirements our team can make the process simple.

Packaging and Labeling

Deficiency letters, the FDA’s formal request for additional information they need to complete the review process of an application, is a critical step in the Substantive Scientific Review phase of the PMTA process. Applicants typically have 90 days to address any deficiencies identified and provide additional data to supplement informational gaps. Applicants that fail to address these deficiencies properly are likely to receive a Marketing Denial Order (MDO) for their application.

Child Resistant Packaging

From 2017 to 2021, the number of children under 6 years old accidently ingesting edible cannabis products increased by 1,375% (Source: American Academy of Pediatrics). It is critical that manufactures take a preemptive approach to age-gating their products, helping to mitigate the risk of accidental ingestion by children. Accorto can provide you with custom child resistant packaging solutions tailored to your unique product type. From off-the-shelf solutions to custom packaging and testing, our team has the resources to help ensure your products are accessed only by the populations are intended for.

Product Labeling

For product labels in regulated, or soon to be regulated, product space, it’s often true that what is included on the label is just as important as what isn’t. Brand holders in the regulated product space must be conscious of including all necessary warnings and product information users would need to make an informed decision on whether the use of the product is right for them, especially users of vulnerable populations, such as users who are pregnant or have preexisting health conditions. However, they must also be cautious as to not include names or design features that would make the product attractive to the wrong audience, such as minors.

Accorto specializes in regulated consumer product label reviews, addressing aspects such as youth appeal, product warnings required at both national and state levels, product use instruction comprehension, and health claims. We offer both in-house label review and consultation as well as full consumer comprehension research studies.